Reed Smith Client Alerts

Authors: Carol Colborn Loepere Catherine A. Hurley Debra A. McCurdy Elizabeth B. Carder-Thompson Katie C. Pawlitz Paul W. Pitts Robert J. Hill Scot T. Hasselman

Type: Client Alerts

On October 3, 2014, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS (“Proposed Rule”). The OIG will accept comments on the Proposed Rule through December 2, 2014.

With regard to the AKS, the OIG proposes:

  • A technical correction to the existing safe harbor for referral services;
  • Protection for certain cost-sharing waivers, including: pharmacy waivers of cost-sharing for financially needy Medicare Part D beneficiaries, and waivers of cost-sharing for emergency ambulance services furnished by state- or municipality-owned ambulance services;
  • Protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers;
  • Protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
  • Protection both under the AKS and the statutory prohibition on beneficiary inducement for free or discounted local transportation services that meet specified criteria.

Download the .PDF below to read more.